Remembering to accurately take medication is well understood to be a very serious health problem, particularly for the elderly, for whom the taking of multiple medications is common. Often the appropriate efficacy levels of the medication are not reached or maintained, resulting in deterioration of health status and increased need of preventable hospital days and medical procedures. Noncompliance, defined in medical parlance as the failure to follow through with therapy as prescribed by one's physician, is recognized as a major impediment to improved health.
More than 80% of the 36.3 million people over 65 are on an active medication regimen, typically taking multiple medications daily. It is estimated that approximately fifty percent (50%) of patients with illness do not comply with their medication regimen, with the elderly making up a significant portion of this population. Failure to comply with one's medication regimen is associated with deterioration of health status, resulting in an escalation of medical costs for individuals and insurers, as well as an increase in preventable fatalities. The annual cost of noncompliance is estimated to exceed $100 billion.
A significant portion of compliance problems result from patients' difficulty in remembering to properly follow complicated treatment (i.e. multiple medications). The drop off rate for refilling medications for chronic diseases is very high, with up to 75% of monthly prescriptions not refilled after one (1) year. Forgetfulness to self-administer the prescribed medications at the correct daily intervals and correct dosages by patients has long been found to be a major impediment for doctors in determining the effectiveness of prescriptions. It is also well know that the more frequently a medication must be taken, the less likely the patient's compliance. Pharmaceutical companies consequently spend tremendous sums of money and time developing medications that need be taken only once daily, but many medications are simply not amenable to once-daily dosing regimes.
For the patient who must take three, four, or even five dosages of several medications daily, the prescribed regimens can easily become confusing. Many patients carry written timetables with them during the day. Pills are often set up in adjustable packets which can "line up" the medications to be taken. This can be effective, but does not solve the possibility of the patient becoming distracted or simply forgetful.
Some electronic reminder systems do exist, such as that described in U.S. Pat. No. 5,157,640 to Backner (1992). The Backner system utilizes a programmable electronic watch that generates different tones to indicate the number of types of medications to be taken and identifies the medication and dosage in a limited display on the face of the watch. The watch is programmed via connecting pins in a cradle linked to the programming computer. One problem with this approach is that the connecting pins frequently become dirty or damaged, causing the transfer to fail. Metal pins can also cause susceptibility of the system to Electro-Static Discharge (ESD). The Backner system also only allows limited identification information to be transferred from the watch to the host computer and thus does not provide for full two-way information transfer both to and from the watch in order to allow downloading of compliance and patient medical event information to the host computer for review by the physician, pharmacist, or other health care provider.
What is needed, therefore, is a device that can improve and monitor compliance with medication regimens. Such a device should provide automatic auditory and/or visual reminders for both daily medications and health care procedures, and should be programmable by a physician, pharmacist, or other health care provider in an efficient and convenient manner. In addition, such a device should allow two-way information transfer, allowing the patient to enter information into the watch, in order that the patient's compliance and other health events can be monitored by the health care provider.